[Federal Register Volume 85, Number 2 (Friday, January 3, 2020)]
[Notices]
[Pages 316-318]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-28417]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-4824]


Office of Minority Health and Health Equity Strategic Priorities; 
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
opening a public docket to solicit input and comments from interested 
stakeholders, including racial and ethnic minority, underrepresented, 
and underserved populations in establishing strategic priorities for 
the Office of Minority Health and Health Equity (OMHHE). This will help 
the Agency ensure that important health concerns are carefully 
considered in establishing priorities.

DATES: Submit either electronic or written comments by February 28, 
2020.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before February 28, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of February 28, 2020. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2019-N-4824 for ``Office of Minority Health and Health Equity 
Strategic Priorities; Establishment of a Public Docket; Request for 
Comments.'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for

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those submitted as ``Confidential Submissions,'' publicly viewable at 
https://www.regulations.gov or at the Dockets Management Staff between 
9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Christine Merenda, Food and Drug 
Administration, Office of Minority Health and Health Equity, 10903 New 
Hampshire Ave., Bldg. 32, Rm. 2382, Silver Spring, MD 20993, 301-796-
8453, Fax: 301-847-8601, email: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA's OMHHE serves to promote and protect the health of diverse 
populations through research and communication of science that 
addresses health disparities and health equity. Established in 2010, 
OMHHE provides leadership and policy direction for FDA regarding issues 
relating to the health of racial and ethnic minority, underrepresented, 
and underserved populations. OMHHE's stakeholders reflect the diversity 
of the U.S. population, including individuals of low socioeconomic 
status and historically underrepresented populations.
    Currently OMHHE has program areas that focus on outreach and 
communication, as well as research and collaboration. The outreach and 
communication program strives to improve FDA communication with racial 
and ethnic minority populations and leads the Agency's Language Access 
program that provides consumers (including those with limited English 
proficiency) information that is easy to read, culturally competent, 
and available in multiple languages and formats. The research and 
collaboration program supports research projects that study health 
disparities that disproportionately affect racial and ethnic minority, 
underrepresented, and underserved populations, as well as projects that 
analyze data that can answer regulatory science questions. To aid data 
analysis, OMHHE issued a final guidance in October 2016 entitled 
``Collection of Race and Ethnicity Data in Clinical Trials'' (available 
at https://www.fda.gov/media/75453/download) to ensure that 
subpopulation data are collected consistently by industry.
    OMHHE also works with academic institutions as part of the Centers 
of Excellence in Regulatory Science and Innovation, which are 
collaborations between FDA and academic institutions to advance 
regulatory science through innovative research, education, and 
scientific exchanges. In addition, OMHHE supports and collaborates with 
academic institutions and other stakeholders through the Broad Agency 
Announcement (available at https://www.fda.gov/science-research/advancing-regulatory-science/regulatory-science-extramural-research-and-development-projects) to spur innovation in the field of regulatory 
science.
    OMHHE recognizes that more needs to be done to reach the goal of 
health equity and eliminating health disparities. Multiple complex 
factors can affect the health of racial and ethnic minority, 
underrepresented, and underserved populations, some of which are 
outside the purview of FDA, so it is important for OMHHE to develop a 
list of priorities to focus our efforts where FDA engagement can have 
the most impact.
    FDA believes it is crucial to ask for input from the public, 
through Federal Register notices, public meetings, and workshops. OMHHE 
would like to have input from interested stakeholders including, racial 
and ethnic minority, underrepresented, and underserved populations in 
establishing strategic priorities for the office. This will help ensure 
that important health concerns are carefully considered in establishing 
priorities. Therefore, FDA is issuing this Federal Register notice to 
open a docket (FDA-2019-N-4824) for the public to submit comments on 
priorities for FDA's OMHHE. FDA will take the suggestions and 
information submitted to the docket into consideration when developing 
the priorities for OMHHE.

II. Request for Comments

    FDA engagement can have a direct impact on advancing health equity 
in a number of areas, such as:
     Efforts that generate clinical evidence to improve 
generalizability of clinical trial findings and bridge the knowledge 
gap about the medical products' performance in racial and ethnic 
minority populations.
     Direct outreach to racial and ethnic minority, 
underrepresented, and underserved populations to promote access to 
relevant information on medical products to improve safety and 
efficacy.
     Coordination with other Federal Agencies and external 
stakeholders to support research on medical products that can address 
health disparities.
     Performing direct outreach to racial and ethnic minority, 
underrepresented, and underserved populations (e.g., raising awareness 
on inclusion of racial and ethnic minority populations in clinical 
trials).
     Leading the identification of regulatory decisions that 
can benefit from participation of racial and ethnic minority, 
underrepresented, and underserved populations.
     Generating research topics/interests and areas of focus 
that predominantly affect racial and ethnic minority populations.
     Identification of opportunities of collaboration to 
generate efforts to address research gaps that predominantly affect 
racial and ethnic minority populations.
    We encourage interested stakeholders to submit comments on the 
areas and types of engagement FDA's OMHHE should prioritize in the 
coming year(s), and potential mechanisms that can be used to implement 
them (e.g., through collaborations and partnerships).


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    Dated: December 30, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-28417 Filed 1-2-20; 8:45 am]
 BILLING CODE 4164-01-P